FDA Adverse Event
Malfunction
Summary report: N
IMPRESS DIAGNOSTIC PERIPHERAL CATHETER
MDR report key: 3202065
·
Received June 27, 2013
Report
- Report Number
- 1628221-2013-00016
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- May 13, 2013
- Report Date
- June 3, 2013
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DQO
- PMA / PMN Number
- K093004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE USER REPORTED THAT DURING A FIBROID EMBOLIZATION PROCEDURE THE CATHETER KINKED IN THE PT WHEN IT WAS MANEUVERED FROM THE FEMORAL ARTERY AROUND THE ILIAC BIFURCATION. THE USER THEN SWITCHED TO A NEW CATHETER. NO HARM OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291815 | IMPRESS DIAGNOSTIC PERIPHERAL CATHETER | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | MERIT MEDICAL SYSTEMS, INC. | E384565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5F CORDIS SHEATH| CONTRAST MEDIA| 0.035 TERUMO GLIDE WIRE| HEPARIN| SALINE| 0.032 TERUMO GLIDE WIRE |